Duns Number:825673239
Device Description: AMSure® Urethral Self Catheterization Kit 12Fr.with • Pre-lubricated • Closed SystemCONTEN AMSure® Urethral Self Catheterization Kit 12Fr.with • Pre-lubricated • Closed SystemCONTENTS STERILIZEDUSING ETHYLENE OXIDE:1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length1 each 1100 mL Collection Bag with Insertion Tip1 each Waterproof Underpad, 13”x18” (340 x 450 mm)1 pair Cuffed Vinyl Gloves1 each Waste Disposal Bag1 each Gauze Pad, 4”x4”(100 x 100 mm)NON-STERILE CONTENTS:1 pack BZK Swabsticks (3)1 pack Benzalkonium Chloride Prep Pad
Catalog Number
AS85012K
Brand Name
AMSure® Urethral Self Catheterization Kit 12Fr.
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCM
Product Code Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Public Device Record Key
d55c609e-ed33-4a10-a863-235674cb1dd3
Public Version Date
May 29, 2018
Public Version Number
1
DI Record Publish Date
April 28, 2018
Package DI Number
40704411007570
Quantity per Package
50
Contains DI Package
10704411007579
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |